Brainsway Deep (DTMS) System

Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder

Brainsway Ltd.

The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep (dtms) System.

Pre-market Notification Details

Device IDK203616
510k NumberK203616
Device Name:Brainsway Deep (DTMS) System
ClassificationTranscranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Applicant Brainsway Ltd. 19 Hartom Str. Jerusalem,  IL 9777518
ContactAhava Stein
CorrespondentAhava Stein
A. Stein Regulatory Affairs Consulting Ltd. 18 Hataas St., Suite 102 Kfar Saba,  IL 4442520
Product CodeQCI  
CFR Regulation Number882.5802 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-04-16

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